Regulations

BY-LAWS FOR THE WORKING GROUP ”PHARMACEUTICAL STATISTICS AND DATA MANAGEMENT” OF THE BIOMETRICS SECTION (BMS) OF THE NETHERLANDS SOCIETY FOR STATISTICS AND OPERATIONS RESEARCH (VVS-OR)

The activities of the Working Group are governed by the By-Laws of BMS and the following regulations:

1. NameThe name of the Working Group will be ”Pharmaceutical Statistics and Data Management”, but this will generally be abbreviated to PSDM. The Working Group acts under the auspices of the Committee of BMS.

2. ObjectivesThe aims of the Working Group shall be

(a) To provide a forum for regular discussions on statistics and data management and matters relating to the practice of statistics and data management in the pharmaceutical industry.

(b) To promote professional standards of statistics and data management and the standing of the profession in matters pertinent to the pharmaceutical industry.

(c) To establish a central body in the Netherlands to promote contact between Drug Regulatory Authorities and the pharmaceutical industry with respect to matters of statistics and data management, and to participate in the EFSPI – the European Federation of Statisticians in the Pharmaceutical Industry, and in the INCDMA – the International Network of Clinical Data Management Associations.

3. Composition and Business3.1 The Working Group will consist of a group of Affiliates. It will be headed by an executive Committee of at least three Full Members of BMS, including a chairperson and a secretary. It the chairperson is not a member of the Committee of BMS, the chairperson shall become an ex officio member of the Committee of BMS. The chairperson must be employed in the Pharmaceutical Industry and other members must be working in or for the Pharmaceutical Industry. If this condition is no longer met during the term of office, the person involved shall resign at the next Business Meeting.

3.2 All Working Group’s Committee members are appointed for a period of three years, but are eligible for re-appointment once. A roster of resignation will be laid down. The Committee of BMS shall fill casual vacancies, on the proposal of the Working Group’s Committee, until the next Business Meeting. Any member so appointed to a casual vacancy shall hold office only for the unexpired term of his predecessor.

3.3 Candidate members of the Working Group’s Committee shall be proposed by the Business Meeting and shall be appointed by the Committee of BMS. The Working Group’s Committee will sollicit suggestions for candidates beforehand.

3.4 The quorum for meetings of the Working Group’s Committee will be more than half of the number of its members. Decisions will be made by single majority of the votes cast. Abstentions are not counted. In case of a tie, the chairperson of the meeting has the casting vote.

3.5 The Working Group’s Committee will conduct the business necessary to meet its objectives. To this end the committee shall administer a record of Affiliates, i.e. those persons who have expressed an interest in the stated objectives and activities. It shall propagate that these Affiliates be member of BMS and ANed. The Working Group’s Committee has the right to set up whatever ad hoc subgroups it considers necessary. It shall also have the right to decide the composition of those subgroups and how persons should be appointed to serve on them.

3.6 The Working Group’s Committee shall decide on the composition of external delegations. The chairperson shall be among the delegates to the Council of EFSPI.

3.7 The Working Group’s Committee will arrange for a Business Meeting to be held annually or biannually and any other meeting which it considers necessary.

3.8 PSDM is a not-for-profit organisation. All expenditure must be according to the annual budget, which should be approved by the Business Meeting of PSDM. All other expenditure must be approved by the treasurer of BMS who will also audit the annual financial report.

4. Activities4.1 The Working Group’s Committee will organise a Business Meeting annually or biannually, to be notified to the Affiliates at least 4 weeks beforehand. Notice of motions to be placed on the Agenda and suggestions for candidates for the Working Group’s Committee should be submitted to the secretary, in writing, at least 2 weeks before the meeting. The agenda of the Business Meeting shall contain the report of the chairperson, the secretary, financial affairs, the nominations for membership of the Working Group’s Committee and any other proposals as received by the secretary at least 2 weeks before the Meeting. There shall be such other meetings as the Working Group’s Committee deems necessary.

4.2 The fields of interest of PSDM are all areas of the human and veterinary drug development process. including research, preclinical, clinical. post marketing surveillance, production, quality control, marketing and market research.

4.3 Regular meetings and workshops will be organised. Course activities will be offered or promoted.

4.4 Persons on its record who are interested in a special topic can form ad-hoc or permanent subgroups, subject to approval and review by the Working Group’s Committee.

4.5 The Working Group will play an active role in the BMS.

4.6 Contacts with national and international organisations which play a role in Drug Regulatory Affairs will be sought. In particular, PSDM wishes to participate in the EFSPI and INCDMA.

4.7 Contacts with other statistical societies and industry organisations of other disciplines will be fostered.